Guidance document - Fees for the right to sell drugs

Overview

This guidance document provides information to industry and health care professionals on the regulatory requirements for the fees for the right to sell human and veterinary drugs.

Who this guide is for

All drug manufacturers, whereby a manufacturer is any entity or person who holds a Drug Identification Number.

In this guide

• 1. Introduction
  • 1.1 Objective
  • 1.2 Policy statements
  • 1.3 Scope and application
• 2. Guidance
  • 2.1 Regulatory requirements
    • 2.1.1 Annual renewal
    • 2.1.2 Dormant drug identification number
    • 2.1.3 Discontinued sale notification
  • 2.2 Invoicing and fee payment
  • 2.3 Mitigation measures
    • 2.3.1 Small business
    • 2.3.2 Publicly funded health care institutions
    • 2.3.3 Government organizations
  • 2.4 Missed performance standards
  • 2.5 Applicable Fees
  • 2.6 General contact information

View complete guide

Details and history

• Published: 1997/05/01
• Updated: 2019/10/15; 2018/06/13
• Part of topic(s): Guidance on legislation

For assistance

Contact us by mail:

Right-To-Sell and Invoice Inquiries

Office of Submissions and Intellectual Property
By email: hc.annual-annuelle.sc@canada.ca
By fax: 613-954-3067

Invoice Payment Inquiries

Accounts Receivable,
Address Locator: 1918B
18th Floor, Room 1804B, Jeanne-Mance Building
161 Goldenrod Driveway, Tunney’s Pasture
Ottawa, Ontario K1A 0K9
By email: hc.ar-cr.sc@canada.ca
By phone: 613-957-1052 or 1-800-815-0506
By fax: 613-957-3495